The FDA's Secret Database

Through an obscure “exemption” the FDA has allowed medical device manufacturers to hide malfunction reports from doctors and the public, a Kaiser Health News investigation found.
 
Unbeknownst to many medical professionals—and a former FDA commissioner—manufacturers can file malfunction reports through a hidden “alternative summary reporting” system.
 
Instead of using MAUDE, a highly scrutinized public database that doctors rely on, the “vast and hidden repository” available only the FDA has tracked serious incidents involving some 100 devices from surgical staplers to breathing machines.
 
The FDA defended the approach, saying it allows them to “more efficiently review adverse events … and take action when warranted.”

Comments +

0 comments

Post a Comment

Restricted HTML

  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Back to top